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Bebtelovimab

Picture of bebtelovimab

Base photo source: Eli Lilly

Bebtelovimab is no longer authorized for use in any US region.  This page is no longer being updated and exists as an archive.

KEY POINTS

  • On February 11, 2022 the US FDA released an Emergency Use Authorization (EUA) for bebtelovimab which is a monoclonal antibody for COVID-19
  • The EUA for bebtelovimab was revoked on November 30, 2022 due to lack of activity versus BQ.1, BQ.1.1, and XBB variants. With this update, there are now no COVID-19 MABs authorized in the US for treatment of COVID-19.
  • Mechanism: Bebtelovimab is a recombinant neutralizing human IgG1κ monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. Bebtelovimab binds the spike protein with a dissociation constant KD = 0.046 to 0.075 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.39 nM (0.056 mcg/mL).
    • Monoclonal antibodies are a form of passive immunity
    • Bebtelovimab production includes Chines hamster ovary stable bulk culture
    • Bebtelovimab has activity against Omicron variant including BA.1, BA.1.1, and BA.2
    • The activity of monoclonal antibodies for SARS-CoV-2 can vary by variant, the following table was made 12 February 2022 using all of the Fact Sheets for Healthcare Providers…

Here is a PDF to this COVID MAB comparison chart

Bebtelovimab retains activity against Omicron sub-variants BA.5 and BA.5 according to this article.

  • Criteria for qualifying per EUA includes:
    • Having mild-to-moderate COVID-19
    • Being 12 years of age or older
    • Weighing at least 40 kg
    • Having a positive direct SARS-CoV-2 viral test
    • Within 7 days of symptom onset
    • Being at high risk for progression to severe COVID-19 (including hospitalization or death)
      • Qualifying criteria for “at high risk” for progression to severe COVID-19 is broad, see CDC webpage here and the sotrovimab Healthcare Provider Fact Sheet for full details
    • Alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate
      • Note the HCP Fact Sheet says: “There are no adequate, approved and available alternatives to bebtelovimab for the treatment of mild- to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.”
    • Use must occur in a geographic region where infection is likely to have been caused by a susceptible variant of SARS-CoV-2
  • Not authorized for people who are hospitalized due to COVID-19, require oxygen therapy due to COVID-19, or have an increase in baseline oxygen flow rate due to COVID-19 (in people who are already on oxygen at baseline)
    • May be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation
  • The Fact Sheet for Patients and Caregivers must be supplied to the patient/caregiver as part of the EUA
    • The patient/ caregiver must be agreeable to the therapy as part of the EUA
  • Authorized dose is 175 mg given as a single IV dose over at least 30 seconds
    • Note most other IV COVID MABs need to be given over more than 20 minutes when given IV
    • No hepatic or renal adjustments
    • Comes in a single dose vial
      • Must wait 20 minutes for vial to come to room temperature after removing from storage under refrigeration, then can administer dose
        • Should be administered immediately if possible (preservative free product), otherwise is stable 24 hours under refrigeration and 7 hours at room temperature
    • Must flush extension set line with NS after injection to ensure entire dose was given
    • Requires a 60-minute post-infusion monitoring period
  • Bebtelovimab has a warnings for:
    • Hypersensitivity including anaphylaxis and infusion-related reactions
      • May occur up to 24 hours after infusion
      • May be severe and life threatening
    • Clinical worsening of COVID-19 after administration
      • Signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.
    • May be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation
  • Most common side effects are infusion-related reactions, pruritus, and rash
    • Infusion reaction may include: fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g., pre-syncope, syncope), dizziness and diaphoresis.
  • Drug interactions via CYP-450 are unlikely
  • As part of the EUA, medication errors and serious adverse events (e.g., death, inpatient hospitalization) must be reported to FDA Medwatch within 7 calendar days of onset of the event
  • Clinical data with bebtelovimab can be found in the HCP Fact Sheet and are limited at this time
    • Much interest exists in understanding the clinical role of babtelovimab. If the BA.2 sub-variant becomes dominant and has increased escape versus other monoclonal antibodies for SARS-CoV-2, this could drive major interest in bebtelovimab.
  • In the March 2nd, 2022 update to the NIH COVID-19 Guideline placed outpatient therapies in the following rank order: oral nirmatrelvir/ritonavir (Paxlovid) > IV sotrovimab > IV remdesivir for 3 days > molnupiravir = bebtelovimab
  • Bebtelovimab will be free to the consumer and allocated through the Federal and State governments. Infusion charges may apply.
    • Bebtelovimb charge codes can be expected to be posted here
  • Allocation data on bebtelovimab can be expected to be posted here

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